BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AESKUSLIDES ® ANA HEp-2-Gamma; HELIOS® AUTOMATED IFA SYSTEM (IOS-1000)

    Reg #: 3004973408 · FEI: 3004973408 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PHADIA US INC.
    Registration Number
    3004973408
    FEI Number
    3004973408
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4169 COMMERCIAL AVE.
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153117

    Owner / Operator

    Firm Name
    PHADIA AB
    Operator Number
    9004441
    Address
    Rapsgatan 7P, P.O. Box 6460
    City
    UPPSALA
    State
    SE-C
    Postal Code
    75137
    Country
    SE

    Products

    Device Name Product Code
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN

    Proprietary Names

    AESKUSLIDES ® ANA HEp-2-Gamma; HELIOS® AUTOMATED IFA SYSTEM (IOS-1000)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198